The R&D Manager will lead the research and development efforts in the design, testing, and commercialization of innovative spinal medical devices. The ideal candidate will manage a team of engineers while collaborating closely with cross-functional departments to drive projects from concept through regulatory approval and into commercialization.
Key Responsibilities:
- Lead and manage R&D teams, providing technical and strategic direction for spinal device projects.
- Oversee the planning, execution, and completion of R&D projects, ensuring timelines, budgets, and quality standards are met.
- Mentor and develop team members, fostering a culture of innovation, collaboration, and continuous improvement.
- Drive the development of new spinal products and enhancements to existing product lines from concept through commercialization.
- Ensure that R&D projects comply with regulatory standards (FDA, ISO, etc.) and quality assurance requirements.
- Collaborate with cross-functional teams including regulatory, quality, clinical, and marketing to support product launches.
- Identify market needs and trends within the spinal device sector and drive innovation to meet those needs.
- Develop and execute the R&D strategy in alignment with company goals, focusing on cutting-edge technologies and materials.
- Explore new research methodologies, materials, and processes to stay ahead of technological advancements.
- Ensure all R&D activities comply with local and international medical device regulations.
- Partner with regulatory and quality teams to prepare technical documentation for regulatory submissions (FDA, CE, etc.).
- Collaborate with external partners, suppliers, and consultants to support product development initiatives.
- Communicate project progress, risks, and outcomes to senior management and stakeholders regularly.
Qualifications:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (Master’s or PhD preferred).
- 7+ years of experience in medical device R&D, with at least 1 year in a leadership or management role.
- Proven experience in the development of spinal or orthopedic medical devices is highly desirable.
- Experience with product development processes, design controls, and risk management practices in the medical device industry.
- Familiarity with regulatory requirements (FDA 510(k), PMA, CE marking, ISO 13485, etc.).
- Proficiency in CAD software (SolidWorks or similar) and FEA tools.
